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Clinical Trials/NCT02573441
NCT02573441CompletedNot Applicable

KEYS to Succeed: Cognitive and Academic Intervention Program for Children and Adolescents Surviving Cancer

The Hospital for Sick Children1 site in 1 country28 target enrollmentStarted: October 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
28
Locations
1
Primary Endpoint
Wechsler Intelligence Scale for Children - Fourth Edition Integrated

Study Overview

Brief Summary

The study will examine whether school liaison services and home-based parental tutoring can help with academic difficulties of paediatric brain tumour survivors who received cranial spinal radiation and have returned to school. Forty-five patients will participate in the project. All patients will receive psychology liaison services to link resources at the hospital with those in the community. Patients will participate in one of two tutoring programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone calls will be used to support parents using the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities.

Detailed Description

Paediatric brain tumour survivors who receive cranial spinal radiation have learning problems, particularly in mathematics and working memory. Working memory is often described as a "mental workspace" where relevant information is held in mind and processed. Working memory is important in mathematics for holding in mind relevant information and carrying out steps necessary to solve problems.

This study will examine whether school liaison support and home-based parental tutoring can help address the academic difficulties of paediatric brain tumour survivors who have received cranial spinal radiation and who have returned to their community school. Forty five patients will participate in the project. First, all patients will receive psychology liaison services to link resources at the hospital with those in the community in order to provide information regarding the effects of pediatric cancer on learning and facilitate the implementation of appropriate assistive technology and remediation programs. Patients will then participant in one of two tutoring programs over the course of a 12 week period. One group of patients will participate in a program that addresses working memory with the intent of indirectly helping with mathematics skills. This program will be delivered over the internet. Another group of patients will participate in a program using a work book to directly help improve mathematics skills. Weekly phone calls will be used to support parents in doing the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities. The two intervention programs will be compared to a waitlist control group that receives only the liaison service (including academic support through weekly phone calls over the 12 weeks).

The findings from this study will provide evidence about the type of intervention that is most effective at helping paediatric brain tumour survivors improve their mathematics skills and working memory ability.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Has been diagnosed with a brain tumour and treated with cranial radiation
  • •Is between 1 and 10 years following diagnosis
  • •Has English as his or her native language or has had at least two years of schooling in English
  • •Is between the ages of 6 and 17
  • •Less than a Grade 8 equivalent math score

Exclusion Criteria

  • •Is younger than 6 years or older than 17 years of age
  • •Is receiving palliative care

Arms & Interventions

Math + Liaison Service

Experimental

To help with mathematics, participants will be assigned to a workbook based version of the JUMP Math program which will be completed at home with a parent. This intervention focuses on mental math skills. In addition all participants will receive the liaison service program.

Intervention: Liaison Services (Behavioral)

Working Memory + Liaison Service

Experimental

To help with working memory, participants will be assigned to Cogmed, a game-like computer exercise focusing on improving working memory. In addition all participants will receive the liaison service program.

Intervention: Cogmed (Behavioral)

Working Memory + Liaison Service

Experimental

To help with working memory, participants will be assigned to Cogmed, a game-like computer exercise focusing on improving working memory. In addition all participants will receive the liaison service program.

Intervention: Liaison Services (Behavioral)

Liaison Services

Other

Participants in this group will only receive the liaison service program for 12 weeks before being assigned to one of the intervention groups.

Intervention: Liaison Services (Behavioral)

Math + Liaison Service

Experimental

To help with mathematics, participants will be assigned to a workbook based version of the JUMP Math program which will be completed at home with a parent. This intervention focuses on mental math skills. In addition all participants will receive the liaison service program.

Intervention: Jump Math (Behavioral)

Outcomes

Primary Outcomes

Wechsler Intelligence Scale for Children - Fourth Edition Integrated

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of verbal and visual working memory

Woodcock Johnson Academic-Third Edition

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of math Fluency, applied math problems, and qualitative concepts

Behaviour Rating Inventory of Executive Function-Parent Version

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of executive functioning

Wide Range Assessment of Memory and Learning - Second Edition

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of verbal and visual working memory

Automated Working Memory Assessment

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of verbal and visual working memory

Connors' Continuous Performance Test-Second Edition

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of sustained attention

Monitoring Basic Skills Progress

Time Frame: Pre-intervention, 12 weeks after intervention and 6 months follow-up

A measure of mathematics

Secondary Outcomes

  • SAM(Pre-intervention, 12 weeks after intervention and 6 months follow-up)
  • California Verbal Learning Test, Children's Version(Pre-intervention, 12 weeks after intervention and 6 months follow-up)
  • Delis-Kaplan Executive Function System(Pre-intervention, 12 weeks after intervention and 6 months follow-up)
  • CANTAB(Pre-intervention, 12 weeks after intervention and 6 months follow-up)
  • Wechsler Abbreviated Scale of Intelligence - Second Edition(Pre-intervention, 12 weeks after intervention and 6 months follow-up)
  • Wide Range Assessment of Memory and Learning - Second Edition(Pre-intervention, 12 weeks after intervention and 6 months follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Donald Mabbott

Program Head, Neurosciences & Mental Health

The Hospital for Sick Children

Study Sites (1)

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